Trial Outcomes & Findings for Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs (NCT NCT02592707)
NCT ID: NCT02592707
Last Updated: 2023-07-19
Results Overview
AE is defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product, which did not necessarily have a causal relationship with this treatment. A serious AE (SAE) was classified as any untoward medical occurrence that at any dose results in death; AE was life threatening; required inpatient hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was an important medical event that may not result in death. TEAEs are defined as AEs that developed or worsened after start of treatment.
TERMINATED
PHASE1/PHASE2
40 participants
From the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, maximum of 33 months
2023-07-19
Participant Flow
This Phase 1/2, open-label study was conducted in participants with somatostatin receptor positive neuroendocrine tumour (NETs) at 8 investigational sites in Australia, Austria, Canada, Denmark, France, Switzerland and United Kingdom between 06 March 2017 and 22 February 2022. The sponsor terminated the study early for strategic reasons and this decision was not due to any safety or tolerability concern of the study drug.
The study was performed in 2 parts, Part A and Part B. Study consists of a screening period (up to 4 weeks), Treatment period (3 core treatment cycles in each Part A and Part B; 2 additional cycles in Part B only) and followed by long-term follow-up (LTFU) period (2 years). Each cycle was 8 weeks (+ up to 4 weeks if toxicity) apart. A total 40 participants were treated in this study. Due to initial findings, Cohorts 2, 4, 5, 7 and 8 in Part B were not performed in this study.
Participant milestones
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 gigabecquerel (GBq) 177Lu-IPN01072 \[target dose of 300 microgram (mcg) ±50 mcg\] intravenous (IV) infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart \[+2 weeks or up to +4 weeks in case of adverse events (AE) which had not adequately recovered\].
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by data review board (DRB). As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
6
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
1
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
6
|
7
|
Reasons for withdrawal
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 gigabecquerel (GBq) 177Lu-IPN01072 \[target dose of 300 microgram (mcg) ±50 mcg\] intravenous (IV) infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart \[+2 weeks or up to +4 weeks in case of adverse events (AE) which had not adequately recovered\].
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by data review board (DRB). As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
|---|---|---|---|---|
|
Overall Study
Consent Withdrawn
|
0
|
1
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
4
|
4
|
3
|
3
|
|
Overall Study
Other
|
0
|
0
|
1
|
2
|
|
Overall Study
Never entered LTFU period
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs
Baseline characteristics by cohort
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 13.5 • n=21 Participants
|
|
Age, Customized
<65
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Customized
>=65
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, maximum of 33 monthsPopulation: The SAS included all participants who received 177Lu-IPN01072.
AE is defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product, which did not necessarily have a causal relationship with this treatment. A serious AE (SAE) was classified as any untoward medical occurrence that at any dose results in death; AE was life threatening; required inpatient hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was an important medical event that may not result in death. TEAEs are defined as AEs that developed or worsened after start of treatment.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=40 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
15 Participants
|
6 Participants
|
9 Participants
|
10 Participants
|
40 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to EOCT, maximum of 16 weeks.Population: The SAS included all participants who received 177Lu-IPN01072.
DLTs were defined as study medication-related AEs with a severity of Grade 3 or higher are considered DLT, with the exception of hair loss, lymphopenia, nonfebrile neutropenia lasting \<4 weeks and thrombocytopenia lasting \<4 weeks.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=40 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT)
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1Population: The Per Protocol Dosimetry Analysis Set (PP-DAS) included all participants in the Intent-To-Treat Dosimetry Analysis Set (ITT-DAS) for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported.
177Lu-IPN01072 uptake in organs and lesions was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Uptake activity for organs of interest (i.e., body, bone marrow, kidney \[left + right\], healthy liver, and spleen) was determined. The maximal uptake in lesions was calculated for each lesion as: maximal activity divided injected activity\*100.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=11 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=36 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1
Bone marrow (image-based)
|
0.0469 percentage of injected drug activity
Interval 0.0246 to 0.0751
|
0.0420 percentage of injected drug activity
Interval 0.01 to 0.28
|
0.0250 percentage of injected drug activity
Interval 0.0149 to 0.057
|
0.0219 percentage of injected drug activity
Interval 0.0053 to 0.03
|
0.0380 percentage of injected drug activity
Interval 0.0053 to 0.28
|
|
Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1
Liver
|
1.52 percentage of injected drug activity
Interval 0.314 to 6.34
|
4.31 percentage of injected drug activity
Interval 4.31 to 4.31
|
—
|
—
|
2.63 percentage of injected drug activity
Interval 0.314 to 6.34
|
|
Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1
Kidney (left + right)
|
1.96 percentage of injected drug activity
Interval 0.98 to 3.82
|
1.76 percentage of injected drug activity
Interval 1.05 to 2.08
|
1.60 percentage of injected drug activity
Interval 1.19 to 2.51
|
1.67 percentage of injected drug activity
Interval 0.749 to 2.41
|
1.76 percentage of injected drug activity
Interval 0.749 to 3.82
|
|
Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1
Spleen
|
1.50 percentage of injected drug activity
Interval 0.274 to 2.93
|
1.27 percentage of injected drug activity
Interval 0.96 to 2.46
|
1.78 percentage of injected drug activity
Interval 0.55 to 5.97
|
1.79 percentage of injected drug activity
Interval 1.19 to 2.65
|
1.67 percentage of injected drug activity
Interval 0.274 to 5.97
|
|
Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1
All lesions
|
0.651 percentage of injected drug activity
Interval 0.029 to 6.35
|
2.36 percentage of injected drug activity
Interval 0.266 to 8.74
|
1.18 percentage of injected drug activity
Interval 0.235 to 18.7
|
1.43 percentage of injected drug activity
Interval 0.19 to 15.0
|
0.932 percentage of injected drug activity
Interval 0.029 to 18.7
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1Population: The radiopharmaceutical pharmacokinetic (PK) set included all participants in the ITT set who received at least 1 dose of study medication and had at least 1 measured radioactive concentration in blood. Only data from the participants analyzed were reported.
177Lu-IPN01072 uptake in blood was evaluated on site/locally using a gamma counter calibrated for 177Lu-IPN01072 according to the dosimetry operational manual.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=13 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=8 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=37 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Maximal Uptake (%) of 177Lu-IPN01072 in Blood in Cycle 1
|
3.66 percentage/liter (L)
Interval 2.17 to 7.88
|
2.98 percentage/liter (L)
Interval 2.26 to 4.35
|
2.77 percentage/liter (L)
Interval 1.98 to 7.35
|
3.32 percentage/liter (L)
Interval 0.539 to 4.11
|
3.03 percentage/liter (L)
Interval 0.539 to 7.88
|
SECONDARY outcome
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1Population: The PP-DAS included all participants in the ITT-DAS for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported.
The AUC of 177Lu-IPN01072 radioactivity in discernible organs were computed for each administration of 177Lu-IPN01072.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=11 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=36 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1
Bone marrow (Image-based)
|
174 MBq*hour
Interval 45.3 to 224.0
|
352 MBq*hour
Interval 154.0 to 3988.0
|
138 MBq*hour
Interval 91.0 to 362.0
|
157 MBq*hour
Interval 41.5 to 244.0
|
175 MBq*hour
Interval 41.5 to 3988.0
|
|
Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1
Kidney (left + right)
|
9596 MBq*hour
Interval 3896.0 to 26596.0
|
8966 MBq*hour
Interval 7350.0 to 10586.0
|
6239 MBq*hour
Interval 5853.0 to 11269.0
|
7578 MBq*hour
Interval 3320.0 to 9815.0
|
8239 MBq*hour
Interval 3320.0 to 26596.0
|
|
Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1
Liver
|
6745 MBq*hour
Interval 755.0 to 20751.0
|
17918 MBq*hour
Interval 17918.0 to 17918.0
|
—
|
—
|
11133 MBq*hour
Interval 755.0 to 20751.0
|
|
Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1
Spleen
|
6701 MBq*hour
Interval 1134.0 to 21451.0
|
7949 MBq*hour
Interval 4945.0 to 11734.0
|
7727 MBq*hour
Interval 1547.0 to 28269.0
|
8179 MBq*hour
Interval 3901.0 to 12355.0
|
7772 MBq*hour
Interval 1134.0 to 28269.0
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1Population: The radiopharmaceutical PK set included all participants in the ITT set who received at least 1 dose of study medication and had at least 1 measured radioactive concentration in blood. Only data from the participants analyzed were reported.
The AUC of 177Lu-IPN01072 radioactivity in blood were computed for each administration of 177Lu-IPN01072.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=13 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=8 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=37 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
AUC of 177Lu-IPN01072 in Blood in Cycle 1
|
623 MBq*hour/L
Interval 299.0 to 1003.0
|
901 MBq*hour/L
Interval 442.0 to 1806.0
|
690 MBq*hour/L
Interval 371.0 to 1201.0
|
720 MBq*hour/L
Interval 290.0 to 1034.0
|
726 MBq*hour/L
Interval 290.0 to 1806.0
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1Population: The radiopharmaceutical PK set included all participants in the ITT set who received at least 1 dose of study medication and had at least 1 measured radioactive concentration in blood. Only data from the participants analyzed were reported.
The terminal half-life was defined as the largest half-life of the decay curve of blood activity.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=13 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=8 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=37 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Terminal Half-Life (T1/2) of Radioactivity Concentrations of the Radiopharmaceutical in Blood in Cycle 1
|
68.3 hours
Interval 42.2 to 160.0
|
109 hours
Interval 38.6 to 160.0
|
123 hours
Interval 41.2 to 160.0
|
145 hours
Interval 55.3 to 160.0
|
127 hours
Interval 38.6 to 160.0
|
SECONDARY outcome
Timeframe: 4, 24, 48, 72 to 96 and 144 to 168 hours post infusion in Cycle 1Population: The PP-DAS included all participants in the ITT-DAS for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported.
The absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. The organs considered for 177LU-IPN01072 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. Highest absorbed dose of 177Lu-IPN01072 was calculated as described in the Dosimetry calculation procedure manual. Maximum value observed for each discernible organs across participants has been reported.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=11 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=36 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1
Spleen
|
8.07 Gray
|
6.00 Gray
|
5.90 Gray
|
4.09 Gray
|
8.07 Gray
|
|
Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1
Bone marrow (image-based assay)
|
0.97 Gray
|
3.59 Gray
|
0.50 Gray
|
0.69 Gray
|
3.59 Gray
|
|
Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1
Kidney (left + right)
|
8.55 Gray
|
4.87 Gray
|
5.86 Gray
|
5.07 Gray
|
8.55 Gray
|
|
Highest Absorbed Dose of 177LU-IPN01072 to Each Discernible Organ in Cycle 1
Liver
|
1.26 Gray
|
0.81 Gray
|
—
|
—
|
1.26 Gray
|
SECONDARY outcome
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1Population: The PP-DAS included all participants in the ITT-DAS for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported.
The specific absorbed dose was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Data are presented for all lesions, regardless of their anatomical localization. The organs considered for 177Lu-IPN01072 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. The specific absorbed dose to the lesions was the absorbed dose by the lesion (unit: Gray) divided by the injected radioactivity (unit: GBq) for each lesion selected for dosimetry evaluation. The specific absorbed dose for a given organ was the absorbed dose by this organ (unit: Gray) divided by the injected radioactivity (unit: GBq).
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=11 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=36 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1
Lesions
|
2.56 Gray/GBq
Interval 0.431 to 14.3
|
3.90 Gray/GBq
Interval 1.92 to 83.3
|
6.82 Gray/GBq
Interval 2.07 to 28.2
|
13.5 Gray/GBq
Interval 2.2 to 81.0
|
5.00 Gray/GBq
Interval 0.431 to 83.3
|
|
Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1
Bone marrow (image-based)
|
0.0796 Gray/GBq
Interval 0.0431 to 0.216
|
0.135 Gray/GBq
Interval 0.09 to 0.61
|
0.0850 Gray/GBq
Interval 0.07 to 0.11
|
0.0650 Gray/GBq
Interval 0.01 to 0.15
|
0.0900 Gray/GBq
Interval 0.01 to 0.61
|
|
Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1
Kidney (left + right)
|
1.05 Gray/GBq
Interval 0.522 to 1.85
|
0.720 Gray/GBq
Interval 0.6 to 1.02
|
0.880 Gray/GBq
Interval 0.46 to 1.18
|
0.765 Gray/GBq
Interval 0.42 to 1.1
|
0.879 Gray/GBq
Interval 0.42 to 1.85
|
|
Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1
Liver
|
0.186 Gray/GBq
Interval 0.146 to 0.279
|
0.170 Gray/GBq
Interval 0.17 to 0.17
|
—
|
—
|
0.179 Gray/GBq
Interval 0.146 to 0.279
|
|
Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1
Spleen
|
0.769 Gray/GBq
Interval 0.208 to 1.79
|
0.945 Gray/GBq
Interval 0.5 to 1.08
|
0.985 Gray/GBq
Interval 0.18 to 1.46
|
0.805 Gray/GBq
Interval 0.36 to 0.98
|
0.840 Gray/GBq
Interval 0.18 to 1.79
|
SECONDARY outcome
Timeframe: 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycles 1 and 3Population: The PP-DAS included all participants in the ITT-DAS for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported.
The cumulative absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=11 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=36 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
Cycle 1: Bone marrow (image-based)
|
0.319 Gray
Interval 0.102 to 0.974
|
0.715 Gray
Interval 0.39 to 3.59
|
0.375 Gray
Interval 0.26 to 0.5
|
0.285 Gray
Interval 0.04 to 0.69
|
0.400 Gray
Interval 0.04 to 3.59
|
|
Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
Cycle 1: Kidney (left + right)
|
4.31 Gray
Interval 2.17 to 8.07
|
3.85 Gray
Interval 3.36 to 4.58
|
3.25 Gray
Interval 1.79 to 5.34
|
3.55 Gray
Interval 1.74 to 4.88
|
3.73 Gray
Interval 1.74 to 8.07
|
|
Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
Cycle 1: Liver
|
0.720 Gray
Interval 0.336 to 1.26
|
0.810 Gray
Interval 0.81 to 0.81
|
—
|
—
|
0.765 Gray
Interval 0.336 to 1.26
|
|
Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
Cycle 1: Spleen
|
2.88 Gray
Interval 0.844 to 8.07
|
4.35 Gray
Interval 3.17 to 6.0
|
4.00 Gray
Interval 0.71 to 5.9
|
3.55 Gray
Interval 1.48 to 4.09
|
3.45 Gray
Interval 0.71 to 8.07
|
|
Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
Cycle 3: Bone marrow (image-based)
|
1.11 Gray
Interval 0.636 to 2.17
|
1.48 Gray
Interval 1.48 to 1.48
|
1.09 Gray
Interval 0.83 to 1.24
|
0.840 Gray
Interval 0.29 to 1.23
|
1.10 Gray
Interval 0.29 to 2.17
|
|
Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
Cycle 3: Kidney (left + right)
|
12.3 Gray
Interval 7.67 to 24.1
|
9.41 Gray
Interval 9.41 to 9.41
|
8.91 Gray
Interval 6.29 to 14.0
|
10.1 Gray
Interval 6.95 to 11.5
|
10.8 Gray
Interval 6.29 to 24.1
|
|
Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
Cycle 3: Liver
|
2.08 Gray
Interval 1.01 to 4.14
|
—
|
—
|
—
|
2.08 Gray
Interval 1.01 to 4.14
|
|
Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3
Cycle 3: Spleen
|
6.93 Gray
Interval 4.99 to 15.6
|
7.58 Gray
Interval 7.58 to 7.58
|
9.21 Gray
Interval 2.82 to 14.6
|
8.08 Gray
Interval 5.66 to 14.2
|
8.32 Gray
Interval 2.82 to 15.6
|
SECONDARY outcome
Timeframe: 0 to 6 hours, 6 to 24 hours, 24 to 48 hours post-infusion in Cycle 1 of Part A; 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 of Part B.Population: The Radiopharmaceutical PK Set (Part A and Part B) included all participants in the ITT set who received at least 1 dose of study medication and had at least 1 measured radioactive concentration in blood.
Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=13 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=8 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=36 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Cumulative Amount of Lu-177 Radioactivity Excreted Into the Urine (0 to 48 Hours) [Ae (0-48h)] in Cycle 1
|
2586 Mbq
Interval 1722.0 to 4450.0
|
3106 Mbq
Interval 2558.0 to 3998.0
|
2640 Mbq
Interval 1346.0 to 3375.0
|
2621 Mbq
Interval 471.0 to 3181.0
|
2787 Mbq
Interval 471.0 to 4450.0
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1Population: The IPN01072 PK set in plasma (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and have no major protocol deviations affecting the plasma PK variables and who had a sufficient number of plasma levels to estimate the main PK parameters. Only data from the participants analyzed were reported. Results were combined for IPN01072 PK analysis performed at cycle 1, as pre-specified according to study protocol and the data analysis plan.
The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=16 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of IPN01072 in Cycle 1
|
0.083 hours
Interval 0.0 to 0.28
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1Population: The IPN01072 PK set in plasma (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and have no major protocol deviations affecting the plasma PK variables and who had a sufficient number of plasma levels to estimate the main PK parameters. Only data from the participants analyzed were reported. Results were combined for IPN01072 PK analysis performed at cycle 1, as pre-specified according to study protocol and the data analysis plan.
The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=16 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of IPN01072 in Cycle 1
|
10.7 nanogram (ng)/milliliter (mL)
Standard Deviation 5.47
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1Population: The IPN01072 PK set in plasma (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and have no major protocol deviations affecting the plasma PK variables and who had a sufficient number of plasma levels to estimate the main PK parameters. Only data from the participants analyzed were reported. Results were combined for IPN01072 PK analysis performed at cycle 1, as pre-specified according to study protocol and the data analysis plan.
The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
AUC From Time Zero to Infinity (AUCinf) of IPN01072 in Cycle 1
|
45.8 ng*hour (h)/mL
Standard Deviation 20.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1Population: The IPN01072 PK set in plasma (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and have no major protocol deviations affecting the plasma PK variables and who had a sufficient number of plasma levels to estimate the main PK parameters. Only data from the participants analyzed were reported. Results were combined for IPN01072 PK analysis performed at cycle 1, as pre-specified according to study protocol and the data analysis plan.
The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
T1/2 of IPN01072 in Cycle 1
|
6.09 hours
Standard Deviation 1.59
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1Population: The IPN01072 PK set in plasma (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and have no major protocol deviations affecting the plasma PK variables and who had a sufficient number of plasma levels to estimate the main PK parameters. Only data from the participants analyzed were reported. Results were combined for IPN01072 PK analysis performed at cycle 1, as pre-specified according to study protocol and the data analysis plan.
The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance of IPN01072 (Total CL) in Cycle 1
|
9.58 L/h
Standard Deviation 12.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1Population: The IPN01072 PK set in plasma (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and have no major protocol deviations affecting the plasma PK variables and who had a sufficient number of plasma levels to estimate the main PK parameters. Only data from the participants analyzed were reported. Results were combined for IPN01072 PK analysis performed at cycle 1, as pre-specified according to study protocol and the data analysis plan.
The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vz) of IPN01072 in Cycle 1
|
68.7 Liter
Standard Deviation 52.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 of Part BPopulation: The IPN01072 PK set in urine (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and have no major protocol deviations affecting the urine PK variables and who had all urine IPN01072 levels to estimate the main urine PK parameters. Results were combined for IPN01072 PK analysis performed at cycle 1, as pre-specified according to study protocol and the data analysis plan.
Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 for Part B only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=23 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Ae (0-48h) of IPN01072 in Cycle 1
|
141 mcg
Standard Deviation 65.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 in Part BPopulation: The IPN01072 PK set in urine (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and had no major protocol deviations affecting the urine PK variables and who had all urine IPN01072 levels available to estimate the main urine PK parameters. Results were combined for IPN01072 PK analysis performed at cycle 1, as pre-specified according to study protocol and the data analysis plan.
Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 for Part B only.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=23 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Fraction of IPN01072 Excreted Into the Urine (Fe) in Cycle 1
|
52.9 percentage of drug excreted into urine
Standard Deviation 24.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.Population: The ITT included all participants in the eligible participants set who received study medication.
The ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) as best overall response (BOR) according centralized to response evaluation criteria in solid tumours (RECIST) version 1.1 from investigator assessment. Participants with no tumour assessment after the start of study treatment were not evaluated. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=40 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
40.0 percentage of participants
Interval 12.2 to 73.8
|
32.5 percentage of participants
Interval 18.6 to 49.1
|
SECONDARY outcome
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.Population: The ITT included all participants in the eligible participants set who received study medication.
The DCR was defined as the percentage of participants who achieved a CR, a PR or a stable disease (SD) as BOR according to Investigator assessment RECIST version 1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=40 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
100.0 percentage of participants
Interval 66.4 to 100.0
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
95.0 percentage of participants
Interval 83.1 to 99.4
|
SECONDARY outcome
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.Population: The ITT included all participants in the eligible participants set who received study medication.
The BOR according to RECIST v1.1 was defined as the best response recorded from the initiation of treatment until the EOCT/end of additional cycles (EOAC)/early withdrawal (EW) Visit (during the core study part), prior to the Investigator assessment of PD. Progression was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=40 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Best Overall Response
PR
|
6 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
13 Participants
|
|
Best Overall Response
SD
|
8 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
25 Participants
|
|
Best Overall Response
PD
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Best Overall Response
Not Evaluable (NE)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.Population: The ITT included all participants in the eligible participants set who received study medication.
The PFS was defined as the time from start of study treatment until occurrence of tumour progression or death, according to Investigator assessment RECIST version 1.1. Estimation of the median was based on the Kaplan-Meier method.
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=6 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=3 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=6 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=5 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=20 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
29.7 months
Interval 17.5 to
NA indicates upper limit of confidence interval (CI) was not evaluable due to insufficient number of participants with events.
|
21.2 months
Interval 19.4 to 22.4
|
25.1 months
Interval 5.1 to
NA indicates upper limit of CI was not evaluable due to insufficient number of participants with events.
|
11.1 months
Interval 5.1 to
NA indicates upper limit of CI was not evaluable due to insufficient number of participants with events.
|
28.1 months
Interval 20.0 to
NA indicates upper limit of CI was not evaluable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and EOCT visit (30 months)Population: The ITT included all participants in the eligible participants set who received study medication. Only data from the participants analyzed were reported.
The European Organisation for Research and Treatment of Cancer (EORTC) score questionnaire (QLQ-C30) was used for QoL evaluation. Each scale in the questionnaire were scored (0 to 100) according to the EORTC recommendations in the EORTC QLQ-C30 scoring manual. The scale included a global health status, where high score for the global health status represents a high QoL. The functional scales consisted of physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, where a higher value reflects a better level of function. Nine symptoms scales included nausea and vomiting, pain, fatigue, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties, where a higher value reflects worse symptoms. Baseline was defined as the last non-missing measurement collected prior to the first dose of study drug (Day 1).
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=13 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=1 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=8 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=4 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=26 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit
Global Health Status
|
1.27 score on a scale
Standard Deviation 23.54
|
16.70 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
-6.24 score on a scale
Standard Deviation 14.61
|
29.15 score on a scale
Standard Deviation 28.43
|
3.84 score on a scale
Standard Deviation 23.83
|
|
Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit
Physical functioning
|
-2.05 score on a scale
Standard Deviation 11.03
|
0.00 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.82 score on a scale
Standard Deviation 6.61
|
10.00 score on a scale
Standard Deviation 20.00
|
0.26 score on a scale
Standard Deviation 11.70
|
|
Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit
Role functioning
|
3.85 score on a scale
Standard Deviation 29.79
|
0.00 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.01 score on a scale
Standard Deviation 19.90
|
12.50 score on a scale
Standard Deviation 25.00
|
3.85 score on a scale
Standard Deviation 25.08
|
|
Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit
Emotional functioning
|
11.52 score on a scale
Standard Deviation 30.15
|
-25.00 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
-4.16 score on a scale
Standard Deviation 7.74
|
10.43 score on a scale
Standard Deviation 12.51
|
5.12 score on a scale
Standard Deviation 23.70
|
|
Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit
Cognitive functioning
|
6.41 score on a scale
Standard Deviation 19.89
|
0.00 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
-6.26 score on a scale
Standard Deviation 12.43
|
12.50 score on a scale
Standard Deviation 15.95
|
3.20 score on a scale
Standard Deviation 17.66
|
|
Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit
Social functioning
|
15.38 score on a scale
Standard Deviation 33.65
|
0.00 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
-2.09 score on a scale
Standard Deviation 5.90
|
12.50 score on a scale
Standard Deviation 25.00
|
8.97 score on a scale
Standard Deviation 26.35
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and EOCT visit (30 months)Population: The ITT included all participants in the eligible participants set who received study medication. Only data from the participants analyzed were reported.
The GI.NET21 module was intended for use among participants with gastrointestinal related (GI.- related) neuroendocrine tumours, who vary in disease stage and treatments. The module comprises 21 questions, consisting of 5 scales (endocrine symptoms, G.I. symptoms, treatment related symptom, social function, disease related worries) and 4 single items that assessed muscle /bone pain symptom, sexual function, information/communication function, and body image. Each question was quoted from 1 (not at all) to 4 (very much). Each scale in the questionnaire was scored from 0 to 100. A higher value was equivalent to worse or more problems. Baseline was defined as the last non-missing measurement collected prior to the first dose of study drug (Day 1).
Outcome measures
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=13 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=1 Participants
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=8 Participants
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=4 Participants
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=26 Participants
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit
Endocrine symptoms
|
-5.12 score on a scale
Standard Deviation 13.31
|
11.10 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
-0.00 score on a scale
Standard Deviation 5.93
|
-5.55 score on a scale
Standard Deviation 11.10
|
-2.98 score on a scale
Standard Deviation 11.13
|
|
Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit
G. I. symptoms
|
-3.58 score on a scale
Standard Deviation 13.49
|
-6.70 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
2.50 score on a scale
Standard Deviation 7.04
|
-13.30 score on a scale
Standard Deviation 17.22
|
-3.33 score on a scale
Standard Deviation 12.81
|
|
Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit
Treatment related symptom
|
5.62 score on a scale
Standard Deviation 21.47
|
-6.70 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
9.01 score on a scale
Standard Deviation 15.11
|
-0.30 score on a scale
Standard Deviation 8.15
|
5.28 score on a scale
Standard Deviation 17.56
|
|
Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit
Social function
|
-19.67 score on a scale
Standard Deviation 15.83
|
-22.30 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
-4.15 score on a scale
Standard Deviation 8.29
|
-30.53 score on a scale
Standard Deviation 5.55
|
-16.67 score on a scale
Standard Deviation 15.17
|
|
Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit
Disease related worries
|
-8.98 score on a scale
Standard Deviation 14.63
|
-22.20 score on a scale
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
3.46 score on a scale
Standard Deviation 16.53
|
-18.05 score on a scale
Standard Deviation 13.87
|
-7.06 score on a scale
Standard Deviation 16.37
|
Adverse Events
Part A: 177Lu-IPN01072 4.5 GBq
Part B Cohort 1: 177Lu-IPN01072 6 GBq
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
All Participants
Serious adverse events
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 participants at risk
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 participants at risk
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 participants at risk
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 participants at risk
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=40 participants at risk
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Precursor B-Lymphoblastic Lymphoma
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Asthenia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Tumour Marker Increased
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
Other adverse events
| Measure |
Part A: 177Lu-IPN01072 4.5 GBq
n=15 participants at risk
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
Part B Cohort 1: 177Lu-IPN01072 6 GBq
n=6 participants at risk
Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 3: 177Lu-IPN01072 4.5 GBq
n=9 participants at risk
Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
Part B Cohort 6: 177Lu-IPN01072 4.5 GBq
n=10 participants at risk
Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).
|
All Participants
n=40 participants at risk
Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
80.0%
12/15 • Number of events 24 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
55.6%
5/9 • Number of events 13 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
80.0%
8/10 • Number of events 15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
65.0%
26/40 • Number of events 53 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Diarrhoea
|
53.3%
8/15 • Number of events 18 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
66.7%
6/9 • Number of events 14 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
60.0%
6/10 • Number of events 8 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
52.5%
21/40 • Number of events 41 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Number of events 8 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
44.4%
4/9 • Number of events 12 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
60.0%
6/10 • Number of events 9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
37.5%
15/40 • Number of events 29 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
5/15 • Number of events 7 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
30.0%
3/10 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
25.0%
10/40 • Number of events 14 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
33.3%
5/15 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
2/10 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
8/40 • Number of events 11 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Constipation
|
26.7%
4/15 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
15.0%
6/40 • Number of events 6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Flatulence
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Gastrointestinal Sounds Abnormal
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
2/10 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Abnormal Faeces
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Anorectal Discomfort
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Breath Odour
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Dental Caries
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Lip Dry
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Steatorrhoea
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Asthenia
|
20.0%
3/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
50.0%
3/6 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
50.0%
5/10 • Number of events 11 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
32.5%
13/40 • Number of events 22 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Fatigue
|
60.0%
9/15 • Number of events 13 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
33.3%
3/9 • Number of events 6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
32.5%
13/40 • Number of events 20 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Feeling hot
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Infusion site reaction
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Malaise
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
2/10 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Chills
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Discomfort
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Influenza like illness
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Injection site bruising
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Injection site reaction
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Injection site swelling
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Sense of oppression
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
General disorders
Xerosis
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
60.0%
9/15 • Number of events 14 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
33.3%
3/9 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
50.0%
5/10 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
47.5%
19/40 • Number of events 24 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
2/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
4/40 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
4/40 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Headache
|
33.3%
5/15 • Number of events 7 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
17.5%
7/40 • Number of events 11 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
15.0%
6/40 • Number of events 7 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Dysgeusia
|
13.3%
2/15 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
12.5%
5/40 • Number of events 9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Lethargy
|
20.0%
3/15 • Number of events 8 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 8 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Taste disorder
|
13.3%
2/15 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Hypogeusia
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Nervous system disorders
Sensory disturbance
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
3/15 • Number of events 10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
50.0%
3/6 • Number of events 13 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
8/40 • Number of events 28 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
2/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
33.3%
2/6 • Number of events 6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
15.0%
6/40 • Number of events 13 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
3/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
12.5%
5/40 • Number of events 6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
33.3%
2/6 • Number of events 10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
12.5%
5/40 • Number of events 13 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
4/40 • Number of events 7 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
3/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
17.5%
7/40 • Number of events 7 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Anal fungal infection
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Conjunctivitis
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Cystitis
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Perineal infection
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Tooth abscess
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Vascular disorders
Flushing
|
60.0%
9/15 • Number of events 13 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
30.0%
12/40 • Number of events 21 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Vascular disorders
Hot flush
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
30.0%
3/10 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 7 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
3/15 • Number of events 8 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
44.4%
4/9 • Number of events 14 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
17.5%
7/40 • Number of events 22 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
44.4%
4/9 • Number of events 11 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
12.5%
5/40 • Number of events 13 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
White blood cell count decreased
|
13.3%
2/15 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
4/40 • Number of events 11 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
C-reactive protein increased
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Blood urea increased
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Protein urine present
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
White blood cell count increased
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Albumin urine present
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Bilirubin urine present
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Blood potassium increased
|
6.7%
1/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Blood pressure decreased
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Cardiac murmur
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Cortisol decreased
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Electrocardiogram QT prolonged
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Electrocardiogram ambulatory abnormal
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Investigations
Liver function test increased
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
17.5%
7/40 • Number of events 13 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
5/15 • Number of events 6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
22.2%
2/9 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
17.5%
7/40 • Number of events 9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.3%
2/15 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Respiratory, thoracic and mediastinal disorders
Lung cyst
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.3%
2/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 4 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
2/15 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Injury, poisoning and procedural complications
Burn oesophageal
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Injury, poisoning and procedural complications
Occupational exposure to radiation
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Cardiac disorders
Tachycardia
|
13.3%
2/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
7.5%
3/40 • Number of events 5 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
30.0%
3/10 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
12.5%
5/40 • Number of events 6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Metabolism and nutrition disorders
Increased appetite
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Psychiatric disorders
Depressed mood
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Psychiatric disorders
Sleep disorder
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Ear and labyrinth disorders
External ear pain
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Hepatobiliary disorders
Hepatomegaly
|
13.3%
2/15 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
5.0%
2/40 • Number of events 3 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Product Issues
Product leakage
|
6.7%
1/15 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/15 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/6 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
0.00%
0/9 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were collected from the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, a maximum of 33 months.
The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER